Clinical trial · Interventional
JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation
A Phase Ib/II Trial of JAB-21822 in Combination With Cetuximab in Patients With Advanced Colorectal Cancer, Small Intestine Cancer and Appendiceal Cancer With KRAS G12C Mutation
NCT05194995CI-TRIAL-00105621active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of JAB-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Appendiceal Cancer | Malignant Appendix Neoplasm | ALIAS | 0.90 |
| Small Intestinal Cancer | Malignant Small Intestinal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| JAB-21822 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1b Dose Escalation
- description
- Dose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab.
- interventionNames
- Drug: JAB-21822
- Drug: Cetuximab
- type
- EXPERIMENTAL
- label
- Phase 2 Dose Expansion, Cohort 1
- description
- Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
- interventionNames
- Drug: JAB-21822
- Drug: Cetuximab
- type
- EXPERIMENTAL
- label
- Phase 2 Dose Expansion, Cohort 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must be able to provide an archived tumor sample * Histologically or cytologically confirmed advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.G12C mutation * Must have received at least 1 prior standard therapy * Must have at least 1 measurable lesion per RECIST v1.1 * Must have adequate organ function * Must be able to swallow and retain orally administered medication Exclusion Criteria: * Has brain metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days * Active infection requiring systemic treatment within 14 days * Active HIV, HBV or HCV * Any severe and/or uncontrolled medical conditions * LVEF\<50% assessed by ECHO * QT interval \>470 msec
References
Publications (2)
- DERIVEDJiang L, Luo Y, Liang H, Feng X, Huang Y, Li Y, Wang Z, Xu T, Zou H, Li Z, Shen L, Chen Y, Wang W, Li J. The dynamic evolution of circulating tumor cells during glecirasib treatment predicts survival and resistance in gastrointestinal tumors with KRASG12C mutation. Hum Cell. 2026 Jul 1;39(7):95. doi: 10.1007/s13577-026-01405-0. PMID 42384131
- DERIVEDLi J, Wang Z, Huang J, Ba Y, Cao B, Luo S, Li W, Bai C, Song Z, Xiong J, Zhu L, An G, Zhang Y, Li Z, Li Y, Gu Y, Hu C, Li X, Huang C, Fu Q, Yin X, Liang X, Zhong D, Shi H, Li X, Li Z, Liu L, Wang F, Liang R, Xia G, Wang Z, Wang-Gillam A, Ding Y, Rao Z, Pan W, Lu S, Sun X, Shen L. Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):110-123. doi: 10.1016/S2468-1253(25)00267-5. Epub 2025 Dec 1. PMID 41344351